Balloon catheter having an integral self-sealing inflation valve



Nov. 5, 1968 R. E. SWANSON BALLOON CATHETER HAVING AN INTEGRAL SELF*SEALING INFLATION VALVE Filed April 1, 1965 INVENTOR- jfz'zz ozaz'uwwarz ax/Z r WM iffarrz e75:

Un t s Pat ii Q.

3,409,015 j j. BALLOON CATHETER HAVING AN INTEGRAL SELF-SEALING INFLATION VALVE Reinold E. Swanson, Rehoboth, Mass.,'assignor to 'Da'vol Inc., a corporation of Rhode Island- 9 Filed Apr. 1, 1965, Ser. No. 444,867 7 Claims. (Cl. 128-349) ABSTRACT OF THE DISCLOSURE A primary object of this invention is the provision of a valve adapted to be integrated with an inflating tube, such as the inflating lumen of a catheter, said valve permitting the flow of fluid under pressureinwardly through said lumen, and at the same time normally preventing the flow of fluid outwardly through said lumen.

A primary object of this invention is the provision of novel and improved means for integrating a self-sealing or one-way valve with the proximal end of an inflating lumen of the type normally found in catheters and the like.

Another important object is the provision of a novel and improved self-sealing or one-way valve per se, the construction of said valve being such that it readily lends itself to manufacture and assembly on an extremely economical basis.

A further object is the provision of a self-sealing valve which may be easily and effectively integrated with the proximal end of the inflating lumen of catheters and the' like, and which, although economically feasible to manufacture and assemble, is nevertheless highly effective and durable in use.

Other objects, features and advantages of the invention will become apparent as the description thereof proceeds when considered in connection with the accompanying illustrative drawings.

In the drawings which illustrate the best modepresently contemplated for carrying out the present invention:

FIG. 1 is a front elevational view of a catheter having a self-sealing valve integrated therewith in accordanc with the instant invention;

FIG. 2 is a view similar to FIG. I, mostly in section;

FIG. 3 is a section, on an enlarged scale, taken on line 3-3 of FIG. 2, showing the valve in open position;

FIG. 4 is a view similar to FIG. 3 showing :the valve in closed position;

FIG. 5 is an elevational view, partly in section, showing the valve housing per se;

FIG. 6 is a top plan view of the housing shown in FIG. 5;

FIG. 7 is a bottom plan view of the housing shown in FIG. 5; and

FIG. 8 is a perspective view of the valve member per se which forms a part of the instant invention.

Referring to the drawings, a conventional catheter is shown generally at 10 having a self-sealing valve shown generally at 12 integrated therewith. As stated, the catheter 10 is of completely conventional construction and comprises an elongated flexible shaft 14 of any suitable material, such as rubber or plastic, having drainage eyes 16 located adjacent the distal end 18 of the catheter. A

Pate ted 3 drainage lumen 20 extendslongitudinally through the catheter. shaft and communicates witheyesfidhDrainage lumen,;20 is provided with an enlarged,proximalportion 22 which in use is adapted to interconnect with ,a suitable drainage tube, (not shown) as is wellvknown in the,art. The shaft 14 further comprises an, inflatinglumen .24 which also extendsJongitudinally through thecatheter shaft in side-by-side relation withdrainage lumen 20. The. inflating lumen 24 terminates at its.distal end in an opening 26 forrned,in the catheter wall, said opening permit-- ting communication between the inflating lumen and. an inflatable sac 28, secured to the exterior ofthe catheter, adjacent the distal end thereof, .bnt spaced inwardly from the eyes 16. At its proximal end, inflating lumen 24- sepa rates from the. cathetershaft 1 4 as at.3 0 to facilitate the introduction of pressurized fluid totthe inflating lumen. It

will be obvious that .the introduction. of pressurized, fluid, into and through inflating lumen 24 will cause the, sac 28 to distend ,until the sacbecomes inflated, as shown in broken lines in FIG. 2. It will be understoodthat when a patient is catheterized, the sac 28 in inflated for retention and/or pressure purposes.

The conventional technique for inflating the sac 28 is to introduce a syringe to the proximal end of inflating lumen 14, and by use of the syringe to force air or other fluid through inflating lumen 24 until the sac 28 is inflated. Once the sac has been inflated, the syringe is removed, and it then becomes necessary to provide means for maintaining the sac inflated. This has been done by a variety of ways, such as by providing a physical clamp that pinches the portion 30 of inflating lumen 24 to block fluid flow therethrough. This technique has sometimes proven undesirable since it first of all is necessary that such a clamp be available, and, secondly, it is sometimes difficult to apply the clamp without losing some of the pressure from the inflated sac. Also, even when the portion 30 is so clamped, there is always danger that the clamp is not a completely secure one and that the sac will slowly deflate. Another often-used technique has been to block the proximal end of the inflating lumen with a rubber plug which must then be punctured by a hypodermic needle provided on the syringe, the plug being selfsealing when the needle and syringe are withdrawn. This technique likewise has disadvantages in that it requires use of a very fine needle and, further, in that the operator may inadvertently puncture the wall of the inflating lumen and/or his own fingers. These disadvantages have been overcome by the use of the integrated, self-sealing valve illustrated generally at 12, the details of which will now be described.

The valve 12 actually comprises three separate parts,

1 i.e., a housing 32 (FIG. 5), a valve member 34 (FIG. 8),

reduced bore portion 42. Adjacent the opposite end of bore 38 there is provided an annular inwardly extending rib 44, the purpose of which will hereinafter become apparent. The cylindrical side wall 46 of housing 32 has an open-ended annular channel 48 formed therein, it being noted that the open end of said channel is adjacent the rib 44. It will further be noted that the free edge of the outer wall of said channel is beveled as at 50.

Referring now to FIGS. 3, 4 and 8, it will be seen that aeratrtsenzrag'esar'ars rznia havm outwardly proa cylindrical body 2, bevrneinber wi ll effectively seal the opening 42 s o as to block 2 andprevent' the flow of lfluid therethrough. Iiithis position, the beveled surfaces 54 and 4f l cooperate to lcenter the valve member 34 ahda't the time provide an effective valve seat'therefonin'a manner well known in the valve art. It isimpo'rtaiit to note that the length f the ribs 56 is less than the diameterofjreducedtbore portion 42';' sin ce otherwisethevalve member wou fdnot be able, to move to its'fclosed position, "as illustrated in 'FIG. 4; It will'be understood that the .valve member 34 is mounted in bo re 38 beforethe housing .32 is integrated with the inflating lumen 24fThe assembly of valve member 34 in bore 38 is achieved simply by forcing the valve member upwardly into the bore past the annular rib 44, it being understood that the flexibility of thewall from which rib 44'extends will be suflicient to enable the valve member to easily be forced past the rib 44. Since the valve member 34 is per: fectly symmetrical, the aforedescribed assembly of the valve member and housing 32 is facilitated, since care need not be taken to orient any particular end of valve member 34 with any particular end of bore 38.

Once the valve member 34 has been assembled in the manner above described, the plug 36 is introduced to maintain the valve member captured within housing 32. Plug 36 is of generally cylindrical configuration and is designed so as to be a press fit within the lower end of housing 32. An annular. groove 60 is provided on plug 36, it being understood that the groove 60 will snap-receive the afore-' described rib 44 to lock the plug in assembled relation. A bore 62 extends through plug 36, and, in effect, plug 36 and its bore 62 actually comprise a second reduced bore portion for the bore 38. It is important to note that the diameter of bore 62 is less than the length of the ribs 56, whereupon if valve member 34 is forced downwardly against plug 36, the rib .56 .will bridge the bore 62 to prevent the cylindrical body 52 from engaging said bore so as to seal or block same. a v

Once the housing 32, valve member 34 and plug 36 have been assembled in the abovedescribed manner, the valve 12 is ready for securement to the catheter 10. This securement isaccomplished by sliding theproximal end portion 30 of lumen 24 into the channel 48, as clearly illustrated in FIGS." 3 and 4. As soon as the proximal end of the inflating lumen has been slid into the channel, it may be maintained therein by any suitable means, although in accordance with the instant invention it is preferred to'effect this integration of the parts by crimping the beveled edge 50 of housing 32 inwardly as at 64 so as to securely grip or clamp the tubular wall of the lumen between the inner and outer walls of channel 48. Beveled edge '50 facilitates this crimping operation since it provides a relatively sharp edge that will bite into and better grip the lumen wall. V

In operation and use, when it is desired to inflate the sac 28, a syringe 66 (having no needle at its tip)" is inserted through reduced bore 42, as illustrated in FIG. 3. Since the length of rib 56 is just slightly less than the diameter of reduced bore portion 42, it follows that the inner diameter of the tip portion of syringe 66 is less than the'leng'th of rib 56, whereupon the rib bridges the tip of the syringe to insure that the syringe tip can never engage and abut against body portion 52, since if this were'possible'the' body'52 would'block flow of pres surized fluid from the syringe. Since entry of the syringe 66 through reduced bore portion 42 dislodges the valve member 34 from the position illustrated in FIG. 4 to the position --ill1 1strated in FIG. .3, and since the tip of the syringe is maintained in spaced relation from body portion52 by. virtue of rib 56, it follows that air or fluid under pressure'may be forced through bore 38 (passing around the outer periphery of cylindrical body 52), the pressurized fluid then passing through bore 62 to lumen 24 and then eventually to sac 28 in order to inflate same. As soon as the sac issufliciently inflated, the syringe is removed, -whereupon;.;'back pressure will automatically move the valve member 34 to the closed position illustrated in FIG. 4, thus creating a seal which maintains the sac 28 inflated. If the syringe 66 is inadvertently pushed'in too far, no harm can be done since the lower ribJ-56 will prevent the bottom of cylindrical body 52 fromsealing the'opening 62.'When it is desired to deflate the sac 28, it is simply necessary to introduce a pin of some sort (not shown) through reduced bore portion 42 into engagement with valve member 34, whereupon as the valve member is depressed, the seal will be broken and the sac will commence to deflate.

:It will thus be seen that unique and effective means have been provided for integrating a self-sealing or oneway valve with the inflating lumen of a catheter. Although the valve 12 has been shown and described in combination with the inflating lumen of the cttheter, it will be understood that this valve is actually usable with and applicable to any type of inflating tube, whether associated with a catheter or not.

While there is shown and described herein certain specific structure embodying the invention, it will be manifest to those skilled in the art that various modifications and rearrangements of the parts may be made without departing from the spirit and scope ofv the underlying inventive concept and that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims.

What is claimed is:

1. In combination, a catheter having a tubular inflating lumen at the proximal end thereof, a one-way valve per.-

saidvalve comprising a hollow cylindrical housing, the

cylindrical wall of said housing having an open-ended annular channel formed therein, said channel receiving therein the proximal end of said inflating lumen and means maintaining said inflating lumen in said channel.

2. The combination of claim 1 further characterized in that said last-mentioned .means comprise an inward deflection of the free edge of the outer wall defining said channel, whereby to clamp said inflating lumen within said channel.

3. A self-sealing valve for catheters and the like comprising a cylindrical housing having a bore extending therethrough, annular means at opposite ends of said housing restricting said bore at its opposite ends to define a first reduced portion at one end of said bore and a second reduced portion at the other end thereof, a solid, cylindrical, symmetrical valve member slidably mounted in said bore and having suflicient clearance from the surfacedefining said bore as to freely permit fluid flow through said housing, an outstanding rib extending across each end surface of said valve member, the diameter of said valve, member being greater than that of either reduced portion and the length of said ribs being less than the diameter 0 fsaid first reduced portion and greater than that of said second reduced portion whereby when said member is forced toward said one end of said housing, the adjacent said rib will extend into said first reduced portion and said member will seal off said first reduced portion to block fluid flow through said housing, but when said valve member is forced against the said other end of said housing, the adjacent said rib will bridge said second reduced portion to prevent said member from acting as a seal.

4. The valve of claim 3 further characterized in that the said annular means that define the said second reduced portion is a plug having an opening extending there through, said plug being secured within said bore at the said other end of said housing.

5. A self-sealing valve for catheters and the like comprising a cylindrical housing having a bore extending therethrough, a first reduced portion at one end of said bore and a second reduced portion at the other end thereof, said second reduced portion being define-d by a plug having an opening extending therethrough, which plug is secured with said bore at said other end, a cylindrical, symmetrical valve member slidably mounted in said bore and having sufiicient clearance from the surface defining said bore as to freely permit fluid flow through said housing, an outstanding rib extending across each end surface of said valve member, the diameter of said valve member being greater than that of either reduced portion and the length of said ribs being less than the diameter of said first reduced portion and greater than that of said second reduced portion, whereby when said member is forced toward said one end of said housing, the adjacent said rib will extend into said first reduced portion and said member will seal off said first reduced portion to block fluid flow through said housing, but When said valve member is forced against the said other end of said housing, the adjacent said rib will bridge said second reduced portion to prevent said member from acting as a seal, said housing being of integral, one-piece construction, the cylindrical wall of said housing having an open-ended annular channel formed therein, the open end of said channel being located at said other end of said housing.

6. In combination, a catheter having a tubular inflating lumen at the proximal end thereof, a self-sealing valve for catheters and the like comprising a cylindrical housing having a bore extending therethrough, a first reduced portion at one end of said bore and a second reduced portion at the other end thereof, a cylindrical and symmetrical valve member slidably mounted in said bore and having sufficient clearance from the surface defining said bore as to freely permit fluid flow through said housing, an outstanding rib extending across each end surface of said valve member, the diameter of said valve member being greater than that of either reduced portion and the length of said ribs being less than the diameter of said first reduced portion and greater than that of said second reduced portion, whereby when said member is forced toward said one end of said housing, the adjacent said rib will extend into said first reduced portion and said member will seal off said first reduced portion to block fluid flow through said housing, but when said valve member is forced against the said other end of said housing, the adjacent said rib will bridge said second reduced portion to prevent said member from acting as a seal, and means for securing said valve to said inflating lumen, said securing means comprising an annular openended channel in the cylindrical wall of said housing, said channel open end being located at said other end of said housing, said channel slidably receiving the free end of said inflating lumen therein, and means maintaining said inflating lumen in said channel.

7. The combination of claim 6 further characterized in that said last-mentioned means comprise an inward deflection of the free edge of the outerwall defining said channel, whereby to clamp said inflating lumen within said channel.

References Cited DALTON L. TRULUCK, Primary Examiner. 

